Pediatric Iron DeficiencyPhase 2/3NCT06527391
Choline and Iron Deficiency
A Phase 2/3 study testing choline bitartrate in people with Pediatric Iron Deficiency and Anemia, run by University of Minnesota at 1 site in United States.
Trial summary
BACKGROUND: Iron deficiency limits the neurodevelopmental potential of more than 200 million children each year. Iron therapy is typically started when iron deficiency anemia is first diagnosed after screening for anemia or detection of clinical symptoms of iron deficiency anemia at 12 months of age. Read more about this study
- Who is it for?
- Ages 5 to 7 months
- Conditions the study is for
- Pediatric Iron Deficiency, Anemia
- What is being tested?
- choline bitartrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2025to 21 Sep 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 months +/- 28 days
- Hb < 11.0 g/dL
- ZPP > = 80
- T<37.5°C
- Malaria-negative based on Rapid Diagnostic Test (RDT)
- Mother is HIV-negative.
Who cannot join
- Developmental disorder
- Severe malnutrition (severe wasting or bipedal edema)
- Known sickle cell disease
- Neurologic disorder, brain injury, or other condition affecting brain development
- Not currently breastfeeding
- Birthweight < 2000 g
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 555455
Sarah Cusick, 612-723-1694, scusick@umn.edu
About this study
Official title: Supplemental Choline to Prevent and Treat Learning and Memory Deficits of Early Iron Deficiency: the SupCHO Study
BACKGROUND:
Iron deficiency limits the neurodevelopmental potential of more than 200 million children each year. Iron therapy is typically started when iron deficiency anemia is first diagnosed after screening for anemia or detection of clinical symptoms of iron deficiency anemia at 12 months of age. But iron started at this time does not fully correct earlier iron-deficiency-mediated brain dysfunction, underscoring the need for low-cost, easily implementable adjunct therapies to iron to treat or prevent this dysfunction in high-risk populations.
Read more
GAP Supplementation with the nutrient choline lessens damage to the hippocampus from early-life iron deficiency in pre-clinical models and improves hippocampus-mediated memory in children with Fetal Alcohol Spectrum Disorders. Choline has not been tested in children with iron deficiency anemia, despite strong pre-clinical and clinical evidence supporting a benefit to brain development.
HYPOTHESIS:
Infants with iron deficiency anemia who receive iron and nine months of daily choline supplements will have better scores on specific neurobehavioral tests of recognition memory than infants who receive iron and placebo.
METHODS:
This randomized, double-blinded, placebo-controlled clinical trial will randomize 300 6-month-old infants with iron deficiency anemia at Mulago Hospital, Kampala, Uganda, to iron plus choline or iron plus placebo to test the effect of choline on hippocampus-specific and global neurobehavioral outcomes after nine months.
RESULTS: Pending
IMPACT:
If our hypothesis is correct, choline could be added immediately to standard-of-care treatment for iron deficiency anemia. This intervention could safely mitigate the brain dysfunction of early-life iron deficiency that is often undiagnosed until the hippocampal critical window is closing. This simple, low-cost nutrient could thus have life-long benefit for both individuals and the economic and social prosperity of entire regions.
- Conditions
- Pediatric Iron Deficiency, Anemia
- Being tested
- choline bitartrate, placebo drug
- Keywords
- iron deficiency, choline, anemia
- Medical subject headings
- Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
choline bitartrateDrug
Daily supplementation for 9 months with 200 mg choline bitartrate
placebo drugOther
Daily supplementation for 9 months with identical placebo
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | participants assigned to receive study drug Receives: Drug: choline bitartrate |
| control group | Placebo comparator | participants assigned to receive placebo drug Receives: Other: placebo drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elicited Imitation score
Elicited Imitation outcomes (number of items correctly recalled and number of steps recalled in the correct order for both immediate and delayed recall) at age 15 months, i.e., after nine months of daily supplementation with choline or placebo.
Measured: 9 months (1 month = 28 days) after enrollment
1) Composite Score on the Mullen Scales of Early Learning; 2) Behavior Rating Scale (BRS) composite score; 3) Early Childhood Vigilance Test (ECVT, computerized test for attention).
- Composite Score on the Mullen Scales of Early Learning; 2) Behavior Rating Scale (BRS) composite score; 3) Early Childhood Vigilance Test (ECVT, computerized test for attention).
Measured: 9 months (1 month = 28 days) after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start11 Aug 2025
- Primary completion21 Sep 2027 (estimated)
- Study completion21 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, placebo-controlled trial of 9 months of daily choline supplementation of 300 6-month-old Ugandan infants with iron deficiency anemia
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Cusick, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527391
- Sponsor's protocol ID
- 33410
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cusick SE, Mupere E, Bangirana P, Baluku RI, Kroupina M, Cheatham CL, Wozniak JR, Georgieff MK. Supplemental choline to prevent and treat learning and memory deficits of early-life iron deficiency (The SupCHO Study): study protocol for a randomized, placebo-controlled trial in Ugandan infants with iron deficiency anemia. Trials. 2025 Nov 19;26(1):524. doi: 10.1186/s13063-025-09246-2.
PubMed 41257751
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Choline to Prevent and Treat Learning and Memory Deficits of Early Iron Deficiency: the SupCHO Study
- ClinicalTrials.gov ID
- NCT06527391
- Acronym / sponsor ID
- 33410
- Conditions
- Pediatric Iron Deficiency, Anemia
- Keywords
- iron deficiency, choline, anemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 21 Sep 2027 (estimated)
- Study completion
- 21 Sep 2027 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND:
Iron deficiency limits the neurodevelopmental potential of more than 200 million children each year. Iron therapy is typically started when iron deficiency anemia is first diagnosed after screening for anemia or detection of clinical symptoms of iron deficiency anemia at 12 months of age. But iron started at this time does not fully correct earlier iron-deficiency-mediated brain dysfunction, underscoring the need for low-cost, easily implementable adjunct therapies to iron to treat or prevent this dysfunction in high-risk populations.
GAP Supplementation with the nutrient choline lessens damage to the hippocampus from early-life iron deficiency in pre-clinical models and improves hippocampus-mediated memory in children with Fetal Alcohol Spectrum Disorders. Choline has not been tested in children with iron deficiency anemia, despite strong pre-clinical and clinical evidence supporting a benefit to brain development.
HYPOTHESIS:
Infants with iron deficiency anemia who receive iron and nine months of daily choline supplements will have better scores on specific neurobehavioral tests of recognition memory than infants who receive iron and placebo.
METHODS:
This randomized, double-blinded, placebo-controlled clinical trial will randomize 300 6-month-old infants with iron deficiency anemia at Mulago Hospital, Kampala, Uganda, to iron plus choline or iron plus placebo to test the effect of choline on hippocampus-specific and global neurobehavioral outcomes after nine months.
RESULTS: Pending
IMPACT:
If our hypothesis is correct, choline could be added immediately to standard-of-care treatment for iron deficiency anemia. This intervention could safely mitigate the brain dysfunction of early-life iron deficiency that is often undiagnosed until the hippocampal critical window is closing. This simple, low-cost nutrient could thus have life-long benefit for both individuals and the economic and social prosperity of entire regions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled trial of 9 months of daily choline supplementation of 300 6-month-old Ugandan infants with iron deficiency anemia
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: choline bitartrateparticipants assigned to receive study drug |
| control group | Placebo comparator | Other: placebo drugparticipants assigned to receive placebo drug |
Who may qualify
- Ages
- 5 to 7 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 6 months +/- 28 days
- Hb < 11.0 g/dL
- ZPP > = 80
- T<37.5°C
- Malaria-negative based on Rapid Diagnostic Test (RDT)
Key exclusion criteria (6 listed)
- Developmental disorder
- Severe malnutrition (severe wasting or bipedal edema)
- Known sickle cell disease
- Neurologic disorder, brain injury, or other condition affecting brain development
- Not currently breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| choline bitartrateDaily supplementation for 9 months with 200 mg choline bitartrate | Drug | study group |
| placebo drugDaily supplementation for 9 months with identical placebo | Other | control group |
Primary outcome
Elicited Imitation score
Time frame: 9 months (1 month = 28 days) after enrollment
Elicited Imitation outcomes (number of items correctly recalled and number of steps recalled in the correct order for both immediate and delayed recall) at age 15 months, i.e., after nine months of daily supplementation with choline or placebo.
1) Composite Score on the Mullen Scales of Early Learning; 2) Behavior Rating Scale (BRS) composite score; 3) Early Childhood Vigilance Test (ECVT, computerized test for attention).
Time frame: 9 months (1 month = 28 days) after enrollment
1) Composite Score on the Mullen Scales of Early Learning; 2) Behavior Rating Scale (BRS) composite score; 3) Early Childhood Vigilance Test (ECVT, computerized test for attention).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Derived from this study: PubMed 41257751Cusick SE, Mupere E, Bangirana P, Baluku RI, Kroupina M, Cheatham CL, Wozniak JR, Georgieff MK. Supplemental choline to prevent and treat learning and memory deficits of early-life iron deficiency (The SupCHO Study): study protocol for a randomized, placebo-controlled trial in Ugandan infants with iron deficiency anemia. Trials. 2025 Nov 19;26(1):524. doi: 10.1186/s13063-025-09246-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Cusick principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing choline bitartrate in people with Pediatric Iron Deficiency and Anemia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Cusick (612-723-1694, scusick@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elicited Imitation score (time frame: 9 months (1 month = 28 days) after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06527391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.